PMID 32625872 Re-evaluation of propane-1,2-diol (E 1520) as a food additive Agency re-evaluation opinion · EFSA Journal, 2018 Intake limit of 25 mg/kg kept. Actual exposure stays below it in every population group at both mean and P95.
Key summary
An EFSA Panel opinion re-evaluating the safety of propane-1,2-diol (E 1520). The Scientific Committee on Food had set an intake limit of 25 mg/kg in 1996. The substance is readily absorbed, distributes widely to organs and tissues, and is mainly metabolised by oxidation to lactic and pyruvic acid. Subchronic studies showed no treatment-related effects and there was no genotoxicity concern. A two-year dog study showed haematological changes suggesting increased red blood cell destruction at the top dose of 5,000 mg/kg, while a two-year rat study found no adverse effects up to 2,500 mg/kg, which became the basis for the intake limit. Reproductive and developmental studies showed no adverse effects. Exposure was judged likely overestimated for the categories with data, and neither the mean nor the 95th percentile of the refined scenario exceeded the limit in any population group.
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The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of propane-1,2-diol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propane-1,2-diol. Propane-1,2-diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane-1,2-diol is excreted in the urine. No treatment-related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2-year study in dogs. No adverse effects were reported in a 2-year chronic study in rats with propane-1,2-diol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane-1,2-diol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brand-loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane-1,2-diol (E 1520) at the reported use levels and analytical results. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
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